Eluxadoline
Editor-In-Chief: C. Michael Gibson, M.S., M.D. [1]; Associate Editor(s)-in-Chief: Martin Nino [2]
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Overview
Eluxadoline is a mu-opioid receptor agonist that is FDA approved for the treatment of adults with irritable bowel syndrome with diarrhea (IBS-D).. Common adverse reactions include constipation, nausea and abdominal pain (>5%)..
Adult Indications and Dosage
FDA-Labeled Indications and Dosage (Adult)
Indications
Eluxadoline is indicated in adults for the treatment of irritable bowel syndrome with diarrhea (IBS-D).
Dosage
The recommended dosage of Eluxadoline is 100 mg taken orally twice daily with food.
The recommended dosage of Eluxadoline is 75 mg taken orally twice daily with food in patients who:
- do not have a gallbladder.
- are unable to tolerate the 100 mg dose of Eluxadoline.
- are receiving concomitant OATP1B1 inhibitors.
- have mild (Child-Pugh Class A) or moderate (Child-Pugh Class B) hepatic impairment.
Discontinue Eluxadoline in patients who develop severe constipation for more than 4 days.
Instruct patients if they miss a dose, take the next dose at the regular time and not to take 2 doses at the same time to make up for a missed dose.
Off-Label Use and Dosage (Adult)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Eluxadoline in adult patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Eluxadoline in adult patients.
Pediatric Indications and Dosage
FDA-Labeled Indications and Dosage (Pediatric)
Safety and effectiveness in pediatric patients have not been established.
Off-Label Use and Dosage (Pediatric)
Guideline-Supported Use
There is limited information regarding Off-Label Guideline-Supported Use of Eluxadoline in pediatric patients.
Non–Guideline-Supported Use
There is limited information regarding Off-Label Non–Guideline-Supported Use of Eluxadoline in pediatric patients.
Contraindications
There is limited information regarding Eluxadoline Contraindications in the drug label.
Warnings
There is limited information regarding Eluxadoline Warnings' in the drug label.
Adverse Reactions
Clinical Trials Experience
There is limited information regarding Eluxadoline Clinical Trials Experience in the drug label.
Postmarketing Experience
There is limited information regarding Eluxadoline Postmarketing Experience in the drug label.
Drug Interactions
There is limited information regarding Eluxadoline Drug Interactions in the drug label.
Use in Specific Populations
Pregnancy
Pregnancy Category (FDA):
There is no FDA guidance on usage of Eluxadoline in women who are pregnant.
Pregnancy Category (AUS):
There is no Australian Drug Evaluation Committee (ADEC) guidance on usage of Eluxadoline in women who are pregnant.
Labor and Delivery
There is no FDA guidance on use of Eluxadoline during labor and delivery.
Nursing Mothers
There is no FDA guidance on the use of Eluxadoline in women who are nursing.
Pediatric Use
There is no FDA guidance on the use of Eluxadoline in pediatric settings.
Geriatic Use
There is no FDA guidance on the use of Eluxadoline in geriatric settings.
Gender
There is no FDA guidance on the use of Eluxadoline with respect to specific gender populations.
Race
There is no FDA guidance on the use of Eluxadoline with respect to specific racial populations.
Renal Impairment
There is no FDA guidance on the use of Eluxadoline in patients with renal impairment.
Hepatic Impairment
There is no FDA guidance on the use of Eluxadoline in patients with hepatic impairment.
Females of Reproductive Potential and Males
There is no FDA guidance on the use of Eluxadoline in women of reproductive potentials and males.
Immunocompromised Patients
There is no FDA guidance one the use of Eluxadoline in patients who are immunocompromised.
Administration and Monitoring
Administration
There is limited information regarding Eluxadoline Administration in the drug label.
Monitoring
There is limited information regarding Eluxadoline Monitoring in the drug label.
IV Compatibility
There is limited information regarding the compatibility of Eluxadoline and IV administrations.
Overdosage
There is limited information regarding Eluxadoline overdosage. If you suspect drug poisoning or overdose, please contact the National Poison Help hotline (1-800-222-1222) immediately.
Pharmacology
There is limited information regarding Eluxadoline Pharmacology in the drug label.
Mechanism of Action
There is limited information regarding Eluxadoline Mechanism of Action in the drug label.
Structure
There is limited information regarding Eluxadoline Structure in the drug label.
Pharmacodynamics
There is limited information regarding Eluxadoline Pharmacodynamics in the drug label.
Pharmacokinetics
There is limited information regarding Eluxadoline Pharmacokinetics in the drug label.
Nonclinical Toxicology
There is limited information regarding Eluxadoline Nonclinical Toxicology in the drug label.
Clinical Studies
There is limited information regarding Eluxadoline Clinical Studies in the drug label.
How Supplied
There is limited information regarding Eluxadoline How Supplied in the drug label.
Storage
There is limited information regarding Eluxadoline Storage in the drug label.
Images
Drug Images
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Package and Label Display Panel
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Patient Counseling Information
There is limited information regarding Eluxadoline Patient Counseling Information in the drug label.
Precautions with Alcohol
Alcohol-Eluxadoline interaction has not been established. Talk to your doctor about the effects of taking alcohol with this medication.
Brand Names
There is limited information regarding Eluxadoline Brand Names in the drug label.
Look-Alike Drug Names
There is limited information regarding Eluxadoline Look-Alike Drug Names in the drug label.
Drug Shortage Status
Price
References
The contents of this FDA label are provided by the National Library of Medicine.